System for detecting and reporting fluid levels in an infusion device

ABSTRACT

This disclosure addresses a monitoring device for an infusion system. The device is typically used with an infusion device utilizing a clear reservoir bag holding the supplied fluid. The device uses light sources and sensors to accurately determine the level of the fluid, the amount of fluid being supplied, and when replenishment of the fluid is required. In addition, the device may utilize ultrasound sources and sensors as backups to the light system. The device further includes a data processing module that gathers, stores, and reports data relative to the fluid flow properties of the infusion device.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional application and claims the prioritybenefit of U.S. Serial Number 17/109,061, of same title, filed Dec. 1,2020.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to medical devices, and moreparticularly is a system for detecting and reporting fluid levels in aninfusion device.

SUMMARY

Intravenous therapy is a common practice in hospital. It requiresconstant care and attention from medical personnel, typically nurses.Problems arise if the nurse on duty allows the infusion to run dry, orif the fluid in an infusion bag is not flowing steadily. According tostatistics, more than 50% of the complaints from patients and theirfamily is connected to issues related to infusion procedures. To preventthis, constant monitoring of the infusion system is necessary. This canrepresent a significant drain on manpower. A better monitoringdesign/device can facilitate a hospital’s effort to reduce manpower byreducing the manpower required to monitor infusion processes. This ispart of the overall effort to decrease human resources costs. Reducingthe time required for monitoring tasks can also help medical personnelto pay more attention to other matters not as mundane as monitoringinfusion, thereby increasing the efficiency of the nurses and providingbetter quality of services for patients.

In various embodiments of the present disclosure, a system adapted tomonitor a fluid level in an infusion bag includes an infusion bag thatholds a fluid to be supplied to a patient, at least one light sourcepositioned on a first side of the infusion bag, at least two lightsensors positioned on a second side of the infusion bag, and a controlsystem including means to trigger the at least one light source, toreceive signals from the light sensors, and to transmit information toreporting and warning modules. When fluid is present in a line of travelof light from the first light source, the light is diffracted anddetected by a first one of the light sensors. When fluid is not presentin the line of travel of light from the first light source, the light isnot diffracted and is detected by a second one of the light sensors, thesystem thereby detecting a level of the fluid in the infusion bag.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, wherein like reference numerals refer toidentical or functionally similar elements throughout the separateviews, together with the detailed description below, illustrateembodiments of concepts that include the claimed disclosure, and explainvarious principles and advantages of those embodiments.

The methods and systems disclosed herein have been represented whereappropriate by conventional symbols in the drawings, showing only thosespecific details that are pertinent to understanding the embodiments ofthe present disclosure so as not to obscure the disclosure with detailsthat will be readily apparent to those of ordinary skill in the arthaving the benefit of the description herein.

FIG. 1 depicts an infusion bag device according to various embodimentsof the present invention.

FIG. 2 shows one configuration of the infusion bag with light sourcesand monitoring sensors.

FIG. 3 illustrates another configuration of the infusion bag with lightsources and monitoring sensors.

FIG. 4 shows an infusion bag with a movable mounting device for thelight sources and sensors.

FIG. 5 is a graphical depiction of the system.

DETAILED DESCRIPTION

The present disclosure is directed to devices used to monitor fluidlevels in infusion devices, to determine whether the devices aremaintaining proper flow rates and when the reservoirs need to bereplenished. The monitoring devices use light sources and light sensorsto determine the physical boundaries of the fluid being dispensed.

Referring first to FIG. 1 , a system 100 is configured to monitor andcontrol a fluid level in an infusion bag 101. The infusion bag includesat an upper end of a main body an air vent 102, an inlet 103, and aninjection port 104. The main body of the infusion bag 101 is typicallyformed from a flexible plastic. Preferably, materials adaptable to 3Dprinters are utilized. The bag may even be made from corn powder. Thoseskilled in the art will recognize that many materials are suitable foruse in forming the infusion bag 101.

The air vent 102 provides a means for maintaining an appropriate airpressure in the body of the bag 100 so that fluid flow may occurproperly. The inlet 103 provides the mechanism whereby the fluid beingused in the infusion process is supplied to the infusion bag 100. Theinjection port 104 allows a caregiver to inject additional requiredfluids into the infusion bag 100.

FIG. 2 illustrates the basic concept of the monitoring function of theinfusion system. The infusion bag 101 is mounted between a light sourcemount 201 and a light sensor mount 202. The light source mount 201includes at least one light source 203. The at least one light source203 is positioned to direct light through the infusion bag 100. Thelight is detected by one of at least two light sensors 204. When fluidis present in the path of the light emitted from the light source 203,the light is refracted by the fluid, so that it is detected by a firstone of the light sensors 204. If no fluid is present in the path of theemitted light, the light travels in a straight line and is detected by asecond one of the light sensors 204. By this mechanism, the system,using a plurality of light sources and sensors, can detect and trackwhen the fluid level drops past a certain point. The system thentriggers a warning and/or a report that the fluid has reached certainlevel. (More about this function follows below.)

FIG. 3 shows another configuration for the sources and sensors of thesystem. It is important for the stationary system illustrated in FIG. 3to have an array of light sources 203, and an array of light sensors204. The light sources 203 are positioned on a first side of theinfusion bag 101. As the fluid level in the bag 101 drops, successivelight sensors 204 will be activated. As each successive sensor 204 inthe array is activated, the system detects and reports the drop of thefluid level in the infusion bag 101. When the lowermost sensor 204 isactivated, the system recognizes that the fluid needs to be replenished,and reports this situation to those individuals (generally nurses)monitoring the system 100. The report may be in the form of a textmessage, a visual alert (graphic or text) on a monitor of the system,and/or an audible alarm.

FIG. 4 shows a system 400 that employs a light bracket 401 with amovable arm 402. The arm 402 moves up and down within the light bracket401, thereby changing the position of the light source / sensor pairs onthe movable arm 402. When the movable arm 402 reaches the bottom of itstravel path, the system 400 recognizes that the fluid in the infusionbag 101 needs replenished, and reports the situation. Again, the reportmay be in the form of a text message, a visual alert (graphic or text)on a monitor of the system, and/or an audible alarm. Those skilled inthe art will recognize that a plethora of mechanical systems may beutilized to move the light source / sensor pairs up and down within theexpanse of the infusion bag 101. Any such mechanism that allows thelight source / sensor pairs to traverse the height of the infusion bag101 will suffice. The system 400 will in various embodiments include astationary base 403 that also includes at least one light source 203 andat least two light sensors 204. The base 403 allows convenientmonitoring of the bottom of the infusion bag 101, where the fluid levelis critical.

An additional benefit to the system depicted in FIG. 4 is that themovement of the arm 402 can be used to physically trigger an alarm forthe system as a backup to the light source and sensors that serve as themain detection mechanism. A contact switch positioned at or near thebottom of the bracket 401 may be triggered when the arm reaches thebottom of its travel path, thereby activating whatever alarm means havebeen chosen by the users. The duplicative detecting mechanisms make thesystem far more reliable than a system with only one mechanism, nearlyfoolproof.

FIG. 5 is a schematic of the overall system for detecting and reportingfluid levels in an infusion device 100. The light sources 203 and lightsensors 204 are in two-way communication with a control system 501. Itis envisioned that in most installations of the system 100, the controlsystem 501 will be an integral part of an MCU (multipoint control unit)of a medical facility in which the system is installed. The controlsystem 501 may include integrated circuits, CPU’s, laptops, or any otherkind of data processing system as may be chosen by the users. In variousembodiments, the light sources 203 and sensors 204 are controlled by andsend data via a wireless IOT (Internet of Things) network.

Once data relative to the fluid level in the infusion bag is received inthe control system 501, whatever reporting is desired is availablethrough a reporting module 502. The reporting module 502 can generatetime / fluid level date for each of the bags being utilized in thesystem. The reports, and particularly any warnings generated, can bemonitored by the appropriate personnel, e.g. nurses. The nurses canreceive the reports and warnings via any smart device, such as theirphone, or a laptop or desk computer. The warning are triggered bypredetermined conditions, such as fluid level, motion detected withinthe system, malfunction of hardware, etc. The reporting module can alsotrigger whatever alarms are desired within the system. Audible alarms,graphics, and written messages are all options.

If desired by the user, a noise management module 503 may be installedin the system. Available options for the noise management module includemeans to detect motion of the bag unit itself, such as installing anaccelerometer in physical contact with the bag itself. Those skilled inthe art can envision multiple other methods of detecting motion in thebag. In a medical setting, two things can happen that interfere with thereadings of the fluid level in the bag. First, patients or their familymay touch the infusion device. This can lead to a large angle swing ormotion of the infusion bag 101. The infusion bag 101 should not have anyacceleration, as any acceleration can interfere with the readingsobtained from the light sensors 204. The second phenomenon is that asmall vibration generated due to movement of the patient may lead tovibration of the fluid in the drip bag. Since the methodology of thesystem relies on determining refraction through the fluid, movement ofthe fluid surface caused by a small amount of vibration of the fluidsurface can lead to inaccurate readings from the light sensors 204.

Therefore, in the case of significant movement, the system can utilizethe accelerometer readings to enable the system to rule out falsereadings due to movement of the device.

For the second case of minor movement, a small vibration may lead tovibration in the light sources 203 and the light sensors 204. If morethan one light sensor 204 receives a signal from a given light source203, the system knows that this signal is due to movement of the device.The signal can therefore be discarded, and if desired, recorded in thereporting module 502. An alarm may also be generated. These procedures,using devices such as an accelerometer and monitoring for false signalsfrom the light sensors 204, provide a method for the system to crosscheck and verify the signals received from the light sensors 204.

The technology disclosed herein addresses improved monitoring systemsfor fluid infusion devices.

The corresponding structures, materials, acts, and equivalents of allmeans or step plus function elements in the claims below are intended toinclude any structure, material, or act for performing the function incombination with other claimed elements as specifically claimed. Thedescription of the present disclosure has been presented for purposes ofillustration and description, but is not intended to be exhaustive orlimited to the present disclosure in the form disclosed. Manymodifications and variations will be apparent to those of ordinary skillin the art without departing from the scope and spirit of the presentdisclosure. Exemplary embodiments were chosen and described in order tobest explain the principles of the present disclosure and its practicalapplication, and to enable others of ordinary skill in the art tounderstand the present disclosure for various embodiments with variousmodifications as are suited to the particular use contemplated.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the technology.As used herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprise” and/or “comprising,” when used in this specification, specify the presenceof stated features, integers, steps, operations, elements, and/orcomponents, but do not preclude the presence or addition of one or moreother features, integers, steps, operations, elements, components,and/or groups thereof.

It will be understood that like or analogous elements and/or components,referred to herein, may be identified throughout the drawings with likereference characters. It will be further understood that several of thefigures are merely schematic representations of the present disclosure.As such, some of the components may have been distorted from theiractual scale for pictorial clarity.

In the foregoing description, for purposes of explanation and notlimitation, specific details are set forth, such as particularembodiments, procedures, techniques, etc. in order to provide a thoroughunderstanding of the present invention. However, it will be apparent toone skilled in the art that the present invention may be practiced inother embodiments that depart from these specific details.

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment of the present invention. Thus, theappearances of the phrases “in one embodiment” or “in an embodiment” or“according to one embodiment” (or other phrases having similar import)at various places throughout this specification are not necessarily allreferring to the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments. Furthermore, depending on the context ofdiscussion herein, a singular term may include its plural forms and aplural term may include its singular form. Similarly, a hyphenated term(e.g., “on-demand”) may be occasionally interchangeably used with itsnon-hyphenated version (e.g., “on demand”), a capitalized entry (e.g.,“Software”) may be interchangeably used with its non-capitalized version(e.g., “software”), a plural term may be indicated with or without anapostrophe (e.g., PE’s or PEs), and an italicized term (e.g., “N+1”) maybe interchangeably used with its non-italicized version (e.g., “N+1”).Such occasional interchangeable uses shall not be consideredinconsistent with each other.

Also, some embodiments may be described in terms of “means for”performing a task or set of tasks. It will be understood that a “meansfor” may be expressed herein in terms of a structure, such as aprocessor, a memory, an I/O device such as a camera, or combinationsthereof. Alternatively, the “means for” may include an algorithm that isdescriptive of a function or method step, while in yet other embodimentsthe “means for” is expressed in terms of a mathematical formula, prose,or as a flow chart or signal diagram.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. The descriptions are not intended to limit the scope of theinvention to the particular forms set forth herein. To the contrary, thepresent descriptions are intended to cover such alternatives,modifications, and equivalents as may be included within the spirit andscope of the invention as defined by the appended claims and otherwiseappreciated by one of ordinary skill in the art. Thus, the breadth andscope of a preferred embodiment should not be limited by any of theabove-described exemplary embodiments.

What is claimed is:
 1. A system adapted to monitor a fluid level in aninfusion bag, comprising: an infusion bag that holds a fluid to besupplied to a patient, at least one light source positioned on a firstside of the infusion bag, at least two light sensors positioned on asecond side of the infusion bag, a control system including means totrigger the at least one light source, to receive signals from the lightsensors, and to transmit information to reporting and warning modules;wherein when fluid is present in a line of travel of light from thefirst light source, the light is diffracted and detected by a first oneof the light sensors, and when fluid is not present in the line oftravel of light from the first light source, the light is not diffractedand is detected by a second one of the light sensors, the system therebydetecting a level of the fluid in the infusion bag.
 2. The system ofclaim 1, wherein: the light sources and the light sensors are configuredas a stationary array.
 3. The system of claim 1, wherein: the controlsystem is in communication with a reporting / warning module.
 4. Thesystem of claim 3, wherein: the reporting / warning module generatesreports regarding the overall system performance, and triggers warningsfor personnel monitoring the system when predetermined conditions occur.5. The system of claim 1, wherein: the control system is incommunication with a noise management module.
 6. The system of claim 5,wherein: the noise management module mitigates difficulties caused byextraneous factors such as movement or vibration of the infusion bag. 7.The system of claim 5, wherein: the noise management module analyzes asignal from an accelerometer to determine if the infusion bag is moving.8. The system of claim 5, wherein: the noise management module analyzessignals from the light sensors to determine if a vibration has affectedthe detection of the fluid level.
 9. A system adapted to monitor a fluidlevel in an infusion bag, comprising: an infusion bag that holds a fluidto be supplied to a patient, at least one light source positioned on afirst side of the infusion bag, at least two light sensors positioned ona second side of the infusion bag, a control system including means totrigger the at least one light source, to receive signals from the lightsensors, and to transmit information to reporting and warning modules;wherein when fluid is present in a line of travel of light from thefirst light source, the light is diffracted and detected by a first oneof the light sensors, and when fluid is not present in the line oftravel of light from the first light source, the light is not diffractedand is detected by a second one of the light sensors, the system therebydetecting a level of the fluid in the infusion bag.
 10. The system ofclaim 9, wherein: the light sources and the light sensors are configuredas a stationary array.
 11. The system of claim 10, wherein: thereporting / warning module generates reports regarding the overallsystem performance, and triggers warnings for personnel monitoring thesystem when predetermined conditions occur.
 12. The system of claim 10,wherein: the control system is in communication with a noise managementmodule.
 13. The system of claim 12, wherein: the noise management modulemitigates difficulties caused by extraneous factors such as movement orvibration of the infusion bag.
 14. The system of claim 12, wherein: thenoise management module analyzes a signal from an accelerometer todetermine if the infusion bag is moving.
 15. The system of claim 12,wherein: the noise management module analyzes signals from the lightsensors to determine if a vibration has affected the detection of thefluid level.